Who is sponsoring NCT01511744?

NCT01511744 is sponsored by Hualan Biological Engineering, Inc..

What condition does NCT01511744 study?

NCT01511744 studies Human Influenza.

What drugs are being tested in NCT01511744?

Interventions: Inactivated influenza split vaccine.

What is the status of NCT01511744?

NCT01511744 is currently COMPLETED.

Last reviewed 2012-08-13 · How we verify

A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)

NCT01511744 Phase 4 COMPLETED

Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immunity of age 3 and older population. Phase III clinical study was conducted in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008. In order to monitor and evaluate the safety and protective effect against influenza administered on age 3 and older population, therefore we conduct the phase IV clinical trial of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).

Details

Lead sponsor	Hualan Biological Engineering, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	6000
Start date	2011-11
Completion	2012-03

Conditions

Human Influenza

Interventions

Inactivated influenza split vaccine

Primary outcomes

Safety study — 28days
Include ADR, adverse event, and severe adverse event.

Countries

China